Kyorin’s KRP-R120 fails primary goal in lung disease trial

Kyorin Pharmaceutical Co., Ltd. announced that its investigational drug KRP-R120 (Efzofitimod) failed to meet the primary endpoint in the global Phase 3 EFZO-FIT™ clinical study for pulmonary sarcoidosis. The study, conducted with partner aTyr Pharma Inc., evaluated KRP-R120's efficacy in reducing mean daily oral corticosteroid (OCS) dose. At week 48, the change from baseline in OCS dose was an average of 2.79 mg for the 5 mg/kg KRP-R120 group, versus 3.52 mg for placebo, with a p-value of 0.3313, indicating no statistical significance.

However, the study reported several nominal findings. Complete steroid withdrawal was achieved in 52.6% of patients on 5 mg/kg KRP-R120 compared to 40.2% on placebo (p=0.0919). The KSQ-lung score showed a change from baseline of 10.36 for 5 mg/kg KRP-R120 versus 6.19 for placebo (p=0.0479). Additionally, 29.5% of patients on 5 mg/kg KRP-R120 achieved complete steroid withdrawal with KSQ-lung improvement, compared to 14.4% on placebo (p=0.0199).

KRP-R120 was reported to be well-tolerated, maintaining a consistent safety profile observed in previous studies. The topline results are scheduled for presentation at the European Respiratory Society Congress on September 30, 2025. Kyorin and aTyr will continue discussions on KRP-R120's future development, with study costs already factored into Kyorin's consolidated earnings forecast for the fiscal year ending March 2026.